High Risk Medical Devices Escaped Close Review

In this file photo, a doctor holds artificial hip joints at Rush University Medical Center in...

In this file photo, a doctor holds artificial hip joints at Rush University Medical Center in Chicago. Some medical devices for sensitive uses, from certain hip joints to a type of defibrillator, have won government approval without a close scientific review, congressional investigators said Thursday.

(Charles Rex Arbogast/AP Photo)

Some medical devices for sensitive uses, from certain hip joints to a type of defibrillator, have won government approval without a close scientific review, congressional investigators said Thursday.

Although Congress ordered the Food and Drug Administration years ago to resolve the issue, the agency approved 228 medical devices without a full scale review from 2003-2007, the Government Accountability Office said in a report.

Some devices approved under the less rigorous process have been recalled because of malfunctions and other problems, according to the consumer group Public Citizen. One device was an external defibrillator to assist heart attack victims.

The report comes as the FDA's Center for Devices and Radiological Health is the subject of allegations that scientists were pressured to approve medical machinery against their professional judgment. Nine FDA scientists wrote the Obama transition team last week complaining that a "corrupted" review process is putting public health at risk.

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The allegations are a separate matter from the concerns raised in Thursday's report. But taken together, they probably will raise the level of congressional scrutiny over the FDA's medical devices branch.

"GAO's investigation confirms my concerns that the approval process for medical devices is woefully inadequate," said Rep. Frank Pallone, who heads the House Energy and Commerce Committee's health panel. "For years, Congress has required high-risk medical devices to undergo stringent premarket review, but GAO's findings show that is simply not happening in every case."

Pallone, D-N.J., said he intends to hold hearings on the FDA's oversight of medical devices. The GAO did not look into whether any patients were harmed as a result of devices that got less government scrutiny.

The root of the problem seems to be that the FDA never fully carried out the intent of a decades-old change in the law.

Medical devices include everything from tongue depressors to silicone breast implants and pacemakers. In 1976, Congress set up a three-tiered classification system for devices.